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OpenTrials
Completed

NCT Number: NCT05742139

Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis

The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the medical world. Some report a frequency of post NBL symptoms similar to the general population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease Symptoms).

In France, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for NBL.

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Key information

Conditions

Neuroborreliosis, Lyme Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Lyme Disease Lyme Neuroborreliosis Nervous System Diseases Quality of Life Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021;
  • Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins);
  • Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21

Exclusion criteria

  • Be part of the entourage of the cases;
  • Do not have ATCD of Lyme borreliosis (especially erythema migrans);
  • Not having been bitten by a tick in the last 5 years;

Treatment and study plan

Non intervention

Other

Non intervention

Primary outcomes

  1. Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity

    Time frame: At inclusion

  2. Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms

    Time frame: At inclusion

Secondary outcomes

  1. Imputability according to the patient of his pain in relation to the initial infection

    Time frame: At inclusion

  2. Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire

    Time frame: At inclusion

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée

Acronym: QoLyme

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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